[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Rules and Regulations]
[Pages 54928-54933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8005]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0617; FRL-8091-6]


Pantoea Agglomerans Strain E325; Exemption from the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Pantoea agglomerans strain E325 on 
apples and pears when applied/used as a microbial pesticide. Northwest 
Agricultural Products submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of Pantoea 
agglomerans strain E325.

DATES: This regulation is effective September 20, 2006. Objections and 
requests for hearings must be received on or before November 20, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part

[[Page 54929]]

178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0617. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5412; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Document Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2006-0617 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before November 20, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0617, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 26, 2006 (71 FR 42395) (FRL-8080-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 6F7086) by Northwest Agricultural Products, 821 South 
Chestnut Ave., Pasco, Washington 99301. The petition requested that 40 
CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of Pantoea agglomerans strain 
E325. This notice included a summary of the petition prepared by the 
petitioner Northwest Agricultural Products. There were no comments 
received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.... 
'' Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency 
consider ``available information concerning the cumulative effects of a 
particular pesticide's residues'' and ``other substances that have a 
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other

[[Page 54930]]

exposures that occur as a result of pesticide use in residential 
settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness, and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    Pantoea agglomerans strain E325 was originally isolated from apple 
blooms in Wenatchee, Washington. Pantoea agglomerans strain E325 was 
isolated from an apple flower stigma by washing the flower in buffer 
and plating dilutions on agar media. The Microbial Pest Control Agent 
(MPCA) was selected from among more than 1,000 bacteria and yeast 
isolates evaluated for potential use in the control of fire blight. 
Screening assays were based on the ability of test organisms to 
colonize the stigma and preemptively exclude the disease organism which 
was introduced 24 hours after treatment with the test organism.
    Pantoea agglomerans is ubiquitous in the environment, and is 
recognized as an epiphyte of a wide variety of plants, such as 
buckwheat, weeds, oilseed rape, sweet potato, rice, and trees of the 
Rosaceae family. Pantoea agglomerans is found on a wide variety of 
plant parts, including the rhizosphere, leaves, and seeds. The species 
is also a heavy colonizer of cotton plants, grass and silage and is the 
prominent species in organic dust. The organism has also been isolated 
from soil and water. Recent reports have also identified P. agglomerans 
on retail salad vegetables.
    Pantoea agglomerans is a common organism of the gut microbiota of 
mosquitos and locusts. In fecal pellets of the locust, the organism is 
responsible for the release of guaiacol and phenol, essential 
components of the locust cohesion pheromone. These components are not 
produced in germ-free locusts. Pantoea agglomerans (Enterobacter 
agglomerans) was also identified in association with sheep scab mites, 
and as an intracellular symbiotic bacteria of the cereal weevil and the 
apple maggot fly. It has been demonstrated that Enterobacter 
agglomerans (in the gut of the fly) is able to detoxify the defense 
chemical (phloridzin) of the apple tree, which would otherwise kill the 
fly.
    Fire blight is caused by the phytopathogenic bacterium Erwinia 
amylovora which colonizes predominately on the stigmatic surfaces of 
the apple or pear. The pathogen may enter the tree through the 
blossoms, leaves, or stem wounds. Usually the disease is spread by 
bacteria that over winter in holdover cankers in the main stem and 
branches or infected twigs. In the spring, when the blossoms begin to 
open, the cankers exude drops of bacterial ooze that are disseminated 
to the blossoms and young leaves by rain, heavy dew, or windblown mist. 
Fire blight may also be spread by pollinating insects such as bees, 
sucking, chewing, or boring insects, and unsanitary pruning tools. Warm 
temperatures (24-28[deg]C) and high humidity are the optimal conditions 
for infection and disease development.
    The disease becomes apparent in the spring, when infected blossoms 
suddenly wilt and turn brown. Later, twigs and leaves also turn brown 
and appear to be scorched by fire. The affected leaves usually remain 
on the tree well into the winter. Young infected fruits become watery 
or oily in appearance and exude droplets of clear, milky, or amber 
colored ooze. They later become leathery and turn brown, dark brown, or 
black, depending on the species. The shriveled fruit usually remains 
attached to the tree.
    Fire blight is considered one of the most destructive diseases of 
fruit trees in North America. It occurs sporadically and unpredictably 
and occasionally reaches epidemic levels. A severe outbreak can 
seriously damage or kill mature pear, apple, or crab apple trees in one 
season. Other ornamentals such as hawthorn, plum, chokecherry, 
saskatoon, cotoneaster, and spirea may also be affected.
    1. Acute oral toxicity/pathogenicity--rats (OPPTS 885.3050). 
Nineteen male and 19 female Sprague-Dawley rats were dosed with the 
test substance, Pantoea agglomerans strain E325, at a rate of 1.05 x 
10\8\ colony forming unit (CFU) per animal. (Master Record 
Identification Number (MRID) 464678-02) (Ref 1). Three animals were 
sacrificed on day 3, 7, and 14. All rats survived to the scheduled 
sacrifice. There was no change in organ weights (brain, blood, cecum 
contents, kidneys, liver, lungs, lymph nodes, and spleen) of male and 
female test animals from beginning of testing to sacrifice. The MPCA 
was detected at high levels in the organs of all test animals. 
Clearance of the MPCA from the blood and lymph node was achieved in all 
test animals. Counts of the MPCA had fallen in the lungs and kidney of 
test animals by day 7. Results from day 14 showed that the MPCA was 
cleared from all organs in all test animals. No clinical manifestations 
of treatment were noted. Gross necropsy revealed no indications of 
treatment-related pathology or any unusual findings. It is concluded 
that Pantoea agglomerans strain E325 is not acutely toxic to rats 
following oral administration.
    2. Acute pulmonary toxicity/pathogenicity--rat (OPPTS 885.3150). 
Forty-eight male and 48 female Sprague-Dawley rats were dosed with the 
test substance, Pantoea agglomerans strain E325 at a rate of 1.8 x 
10\11\ CFU per animal. (MRID 464678-03) Ref 2. The test material was 
determined to be below 100 CFU per animal at all time points tested. 
The test organism (Pantoea agglomerans strain E325) was cleared from 
the cecum contents by day 7 and from the lungs by day 14. The MPCA was 
detected in the kidney and lymph nodes, spleen, and brain up to day 14, 
but had cleared in all animals by day 21. Therefore, based on the 
presented/submitted data, the test organism was not toxic nor 
pathogenic to the test animals.
    3. Acute dermal toxicity--rabbits (OPPTS 870.2500 and OPPTS 
885.3100). The registrant has requested that the dermal irritation 
study be waived. Pantoea agglomerans is found on a wide variety of 
plant parts, including the rhizosphere, leaves, and seeds. The species 
is also a heavy colonizer of cotton plants, grass, and silage, and is 
the prominent species in organic dust. The organism has also been 
isolated from soil and water. Recent reports have also identified P. 
agglomerans on retail salad vegetables. There have been no adverse 
dermal effects or dermal irritation reported in any cited literature 
for Pantoea agglomerans strain E325. In light of the strong evidence 
indicating no adverse effects due to dermal exposure to Pantoea 
agglomerans, EPA has agreed to waive dermal toxicity testing. Further, 
data show that exposure from ambient populations is sufficiently high 
that it indicates there would be no adverse dermal effects from 
pesticidal use no matter what the residue level is.
     4. Primary eye irritation (OPPTS 870.2400). The registrant has 
requested a waiver for the primary eye irritation study. Due to the 
fact that Pantoea agglomerans is found in food and drinking water, and 
there have been no adverse eye irritation effects reported, Pantoea 
agglomerans is not considered to be an eye irritant. Additionally 
Pantoea agglomerans is ubiquitous in the environment, and it is 
recognized as an epiphyte of a wide variety of plants such as sweet 
potato, rice, and organic

[[Page 54931]]

dust. No reports of eye irritation have been reported for this 
organism.
    5. Data waiver requests. Data waiver requests were made for the 
following requirements for the Technical Grade of the Active 
Ingredient/Manufacturing-use Product (TGAI/MP) and Experimental Product 
(EP):
     Acute Intravenous (IV), Intracerebral (IC), 
Intraperitoneal (IP) injection Toxicity/Pathogenicity (OPPTS 885.3200).
     Cell Culture (OPPTS 885.3500).
     Immune Response (OPPTS 880.3800).
     Hypersensitivity study.
     Hypersensitivity Incidents (OPPTS 885.3400).
     i. Acute inhalation toxicity/pathogenicity. The registrant cited 
the acute pulmonary toxicity/pathogenicity study (see Unit III.?.3.) to 
justify waiving the acute inhalation study. In the acute pulmonary 
toxicity/pathogenicity study Pantoea agglomerans strain E325, was not 
found in any organs or tissues which indicates that the active 
ingredient cleared tissues and was not toxic, infective, or pathogenic 
to rats when instilled intratracheally. Additionally, when this product 
is applied, applicators will be required to wear the necessary 
protective equipment to prevent inhalation, and this justifies granting 
this request to waive acute-inhalation data requirements.
     ii. Acute IV/IP/IC study. In an acute oral toxicity/pathogenicity 
study (see Unit III.1. and 2.), no clinical signs of toxicity were 
observed in rats and no Pantoea agglomerans strain E325 was recovered 
from organs or tissues. These data show that Pantoea agglomerans strain 
E325 was considered to clear rapidly from the test animal in that it 
was never detected. The active ingredient Pantoea agglomerans strain 
E325 is considered to be non-toxic. Based on the low toxicity potential 
indicated by these observations, the request to waive the acute IP 
study was granted.
     iii. Cell culture. This study is required for a virus and is not 
required for a bacterial active ingredient such as Pantoea agglomerans 
strain E325.
     iv. Immune response. The lack of pathogenicity seen in the acute 
oral toxicity/pathogenicity study with the active ingredient indicates 
the immune system was not adversely affected by Pantoea agglomerans 
strain E325. Based on these considerations, the justifications to 
support the request to waive data requirements for the immune response 
studies for the TGAI/MP are acceptable.
     v. Hypersensitivity study. No incidents of hypersensitivity have 
occurred during the research, development, or testing of Pantoea 
agglomerans strain E325 or the end use product, Bloomtime. A 
hypersensitivity study is not required at this time, but may be 
required in the future if there are reports of hypersensitivity 
incidents associated with this active ingredient used in pesticides. If 
a person is abnormally physiologically susceptible to a specific agent, 
there are a number of symptoms that the individual will exhibit. This 
organism has been in nature for many years, and there have been no 
reports of any human or animal exhibiting any symptoms after having 
been in contact with the organism.
     vi. Hypersensitivity incidents (OPPTS 885.3400). The registrant 
requested to waive reports of hypersensitivity incidents, because no 
incidents of hypersensitivity associated with the TGAI or the EP have 
been reported. However, the registrant agreed to report 
hypersensitivity incidents, should they occur in the future. This 
guideline requirement is satisfied at this time. In order to comply 
with the Federal Insecticide, Fungicide, and Rotenticide Act (FIFRA) 
requirements under section 6(a)(2), any incident of hypersensitivity 
associated with the use of this pesticide must be reported to the 
Agency. This data requirement has not been waived.
     6. Subchronic, chronic toxicity and oncogenicity, and residue 
data. Based on the data generated in accordance with the Tier I data 
requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III 
data requirements were not triggered and, therefore, not required in 
connection with this action. In addition, because the Tier II and Tier 
III data requirements were not required, the residue data requirements 
set forth in 40 CFR 158.740(b) also were not required.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    Use of Pantoea agglomerans strain E325 is not expected to cause any 
harm via consumption of food or feed treated with the microbial 
pesticide, which is not applied directly to food as discussed in this 
unit.
    1. Food. Residues of Pantoea agglomerans strain E325 are not 
expected on treated food commodities from the proposed use patterns. 
The product, Bloomtime, containing Pantoea agglomerans strain E325, is 
applied at bloom followed by a second application at first petal fall-
full bloom. After Bloomtime is applied, the pesticide becomes non-
viable very rapidly, which causes the need for more than one 
application. The pesticide itself is not in direct contact with the 
food commodities. This pesticide is applied prior to fruiting. There is 
no post-harvest treatment directly to the food commodities. 
Furthermore, the active ingredient is not a systemic pesticide. Thus, 
detectable residues of Pantoea agglomerans strain E325 are not expected 
on treated fruit trees or their food commodities. Furthermore, as 
previously stated, Pantoea agglomerans strain E325 is found in soil, 
water, and air. Data submissions to the Agency show that residues of 
the Pantoea agglomerans strain E325 are not found on the food 
commodities. Finally, as discussed previously in Unit III., the acute 
oral tests demonstrate low toxicity potential via dietary exposure to 
this Toxicity Category IV pesticide. Hence, even if the pesticide was 
present in or on food commodities, exposure via the dietary route is 
not expected to cause any harm. Therefore, the Agency has decided that 
dietary exposure from the proposed uses of Pantoea agglomerans strain 
E325 is not expected to adversely affect the U.S. adult population, 
infants, and children.
    2. Drinking water exposure. No drinking water exposure is 
anticipated because of the use pattern and use sites. There are no 
aquatic use sites permitted for this pesticide, so exposure to drinking 
water is not expected. Further, there is no evidence of adverse effects 
from exposure to this organism. Exposure from the proposed use of 
Pantoea agglomerans strain E325 is not likely to pose any incremental 
risk via consumption of drinking water to adult humans, infants and 
children.

B. Other Non-Occupational Exposure

    The proposed product is an end-use product to be commercially used 
in apple and pear orchards. No non-occupational residential, school or 
day care exposure is anticipated because of the use pattern of this 
product. The use of Panteoa agglomerans strain E325 should result in 
minimal to non-existent, non-occupational risk. No indoor residential, 
school, or daycare uses are permitted on the label of this product.

[[Page 54932]]

    1. Dermal exposure. The low toxicity potential observed in the 
acute dermal studies discussed in Unit III., the low exposure potential 
based on low application rates, and the lack of persistence of the 
active ingredient, leads EPA to conclude that this pesticide poses 
minimal risk to human populations via non-occupational dermal exposure. 
Moreover, potential non-occupational dermal exposure to Panteoa 
agglomerans strain E325 is unlikely because the use sites are 
commercial and agricultural.
     As previously discussed in Units III. and IV., a lack of 
hypersensitivity incidents indicates Panteoa agglomerans strain E325 
poses minimal risk to populations via non-occupational dermal exposure. 
Thus, the Agency does not expect pesticides containing Panteoa 
agglomerans strain E325 to pose a non-occupational dermal exposure 
risk.
    2. Inhalation exposure. Non-occupational inhalation exposure to the 
active ingredient itself is not expected to pose an inhalation risk. No 
treatment-related effects associated with the active ingredient were 
observed in the pulmonary tests reported in Unit II. Based on the low 
potential for non-occupational inhalation exposure, the Agency does not 
expect Pantoea agglomerans strain E325 to pose an inhalation risk.

V. Cumulative Effects

    The Agency has considered the potential for cumulative effects of 
Pantoea agglomerans strain E325 and other substances in relation to a 
common mechanism of toxicity. These considerations include the possible 
cumulative effects of such residues on infants and children. As 
demonstrated in the toxicity assessment, Pantoea agglomerans strain 
E325 is non-toxic and non-pathogenic to mammals. Because no mechanism 
of pathogenicity or toxicity in mammals has been identified for this 
organism, no cumulative effects from the residues of this product with 
other related microbial pesticides are anticipated.

VI. Determination of Safety for U.S. Population, Infants and Children

    There is reasonable certainty that no harm will result to the U.S. 
population, including infants and children, from aggregate exposures to 
residues of Pantoea agglomerans strain E325, as a result of its 
proposed uses. This includes all anticipated dietary exposures and all 
other exposures for which there is reliable information. As discussed 
previously, there appears to be no potential for harm, from this 
bacterium in its use as a microbial pesticide in apple and pear 
orchards. Furthermore, the organism is non-toxic and non-pathogenic to 
animals and humans. The Agency has arrived at this conclusion based on 
the very-low levels of mammalian toxicity for acute oral, pulmonary, 
and dermal effects with no toxicity or infectivity at the doses tested 
(see Unit III.). Moreover, potential non-occupational inhalation or 
dermal exposure is not expected to pose any adverse effects to exposed 
populations via aggregate and cumulative exposure.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of FFDCA, as amended by FQPA, 
to develop a screening program to determine whether certain substances 
(including all pesticide active and other ingredients) ``may have an 
effect in humans that is similar to an effect produced by a naturally-
occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Following the recommendations of its 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
EPA determined that there was scientific basis for including, as part 
of the program, the androgen and thyroid systems, in addition to the 
estrogen hormone system. EPA also adopted EDSTAC's recommendation that 
the program include evaluations of potential effects in wildlife. For 
pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority, to require the wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP). The Agency is not requiring information on the endocrine 
effects of this active ingredient at this time. The Agency has 
considered, among other relevant factors, available information 
concerning whether the microorganism may have an effect in humans 
similar to an effect produced by a naturally-occurring estrogen or 
other endocrine effects.
    There is no known metabolite produced by this bacterium that acts 
as an endocrine disruptor. The submitted and cited toxicity/
pathogenicity studies in rodents indicate that following injection and 
pulmonary routes of exposure, no test substance was found in organs or 
tissues of test animals. This indicates that the body is able to 
process and clear the active ingredient. The Agency concludes that 
there will be no incremental adverse effects to the endocrine system.

B. Analytical Methods

    The acute oral studies discussed in Unit II. demonstrate that the 
active ingredient, Pantoea agglomerans strain E325 does not pose a 
dietary risk. In addition, the active ingredient is not likely to come 
into contact with food commodities. Since residues are not expected on 
treated commodities, the Agency has concluded that an analytical method 
to detect residues of this pesticide on treated food commodities for 
enforcement purposes is not needed. Nevertheless, the Agency has 
concluded that for analysis of the pesticide itself, microbiological 
and biochemical methods exist and are acceptable for enforcement 
purposes for product identity of Pantoea agglomerans strain E325. Other 
appropriate methods are required for quality control to assure that 
product characterization, the control of human pathogens and other 
unintentional metabolites or ingredients are within regulatory limits, 
and to ascertain storage stability and viability of the pesticidal 
active ingredient.

C. CODEX Maximum Residue Level

    There is no CODEX maximum residue level for residues of Pantoea 
agglomerans strain E325.

VIII. Conclusions

    The results of the studies discussed in Unit II. are sufficient to 
comply with the requirements of FQPA. They support an exemption from 
the requirement of a tolerance for residues of Pantoea agglomerans 
strain E325 on apples and pears. In addition, the Agency is of the 
opinion that, if the microbial active ingredient is used as labeled, 
aggregate and cumulative exposures are not likely to pose any undue 
risk. Submitted and cited data show that Pantoea agglomerans strain 
E325 do not pose an incremental dietary and non-dietary risk to the 
adult human U.S. population, children, and infants. Therefore, an 
exemption from tolerance is granted in response to pesticide petition 
6F7087.

MRID Citation References

    1. 464678-02, Kuhn, J.O., Acute Oral Toxicity/Pathogenicity Study 
in Rats With A Microbial Pest Control Agent (MPCA).
    2. 464678-03, Kuhn, J.O., Acute Pulmonary Toxicity/Pathogenicity 
Study In Rats With A Microbial Pest Control Agent (MPCA).

[[Page 54933]]

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, entitled Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the exemption from the 
requirement of a tolerance in this final rule, do not require the 
issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 11, 2006.
James J. Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.1272 is added to subpart D to read as follows:


Sec.  180.1272  Pantoea agglomerans strain E325; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pantoea agglomerans strain E325 when used on apples and 
pears.

[FR Doc. 06-8005 Filed 9-19-06; 8:45 am]
BILLING CODE 6560-50-S